This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Myopore® Sutureless Myocardial Pacing Lead |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | Greatbatch Medical2300 Berkshire Lane Northminneapolis, MN 55441 PMA NumberP130012 Supplement NumberS009 Date Received08/05/2022 Decision Date10/05/2022 Product Code DTB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-08-05 |
| Decision Date | 2022-10-05 |
| PMA | P130012 |
| Supplement | S009 |
| Product Code | DTB |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Greatbatch Medical 2300 Berkshire Lane North minneapolis, MN 55441 PMA NumberP130012 Supplement NumberS009 Date Received08/05/2022 Decision Date10/05/2022 Product Code DTB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Implement A Revised Sterilization Parameter For Myopore Products In An Effort To Reduce The EO Emission |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130012 | Original Filing | |
| S010 | 2022-08-08 | 135 Review Track For 30-day Notice |
| S009 | 2022-08-05 | 30-day Notice |
| S008 | 2019-06-19 | 30-day Notice |
| S007 | ||
| S006 | 2019-01-30 | Special (immediate Track) |
| S005 | 2018-08-27 | 30-day Notice |
| S004 | ||
| S003 | 2017-05-12 | Special (immediate Track) |
| S002 | 2016-08-29 | 30-day Notice |
| S001 | 2016-08-23 | 30-day Notice |